E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families

NCT ID: NCT06939192

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The app-based diagnostic and support approach with a focus on mental and somatic symptoms is intended to strengthen the resilience of premature born children and families and to identify risk and resilience factors.The overall objective of the study is to improve the post-inpatient care of families with premature born children. The procedure is evaluated by a two-arm design with an experimental group and a TAU group.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The project aims to conduct a longitudinal study of premature babies and their parents from the time of hospital discharge in order to identify predictive factors for their psychological and physical outcomes and to provide individualized interdisciplinary diagnostic and treatment. The project helps to identify risk and protective factors and also takes a closer look at the interplay between the mind and body. This care approach is supported by an app that records symptoms and needs and also allows contact with the study team. The app also provides psychoeducational materials. The study was developed in collaboration with affected families and experts from the aftercare team. The concept will be evaluated by comparing the treatment group with a TAU group and by conducting measurements after hospital discharge, after 4 months, and again after 7 months, as well as through focus groups with study participants.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Birth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group (APP)

The participants in the intervention group will be equipped with an app after inclusion in the study. The app contains specific information for parents with premature babies, a contact form for experts and questions about the child's development every 14 days.

Group Type EXPERIMENTAL

Intervention Group (APP)

Intervention Type OTHER

Combination of app-based information and diagnostic screening for parents of premature babies.

Treatment as usual Group (TAU)

Participants in the treatment as usual group do not receive an app after inclusion in the study. They can contact their pediatrician if they have any questions.

Group Type ACTIVE_COMPARATOR

Treatment as usual-Group (TAU)

Intervention Type OTHER

No intervention. Treatment in the form of usual aftercare service is possible.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention Group (APP)

Combination of app-based information and diagnostic screening for parents of premature babies.

Intervention Type OTHER

Treatment as usual-Group (TAU)

No intervention. Treatment in the form of usual aftercare service is possible.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Premature babies born at the UKT,
* Gestational age 28-34 weeks,
* Mother: age ≥ 18 years,
* agreement to participate in this study and signing of a consent form,
* sufficient knowledge of German,
* internet access

Exclusion Criteria

* Premature babies \< 28th or \>34th week of pregnancy,
* at least one of the children has serious diseases of the nervous system or obvious symptoms of a nervous disease,
* at least one of the children has serious congenital diseases or suffers from malformations,
* Mother: Lack of access to a smartphone/tablet,
* no internet access,
* insufficient knowledge of German
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

34 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

PD Dr. Annette Conzelmann

Prof. Dr. Annette Conzelmann

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Annette Conzelmann, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen

Annika K Alt

Role: STUDY_CHAIR

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen

Tobias J Renner, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen

Axel Franz, Prof. Dr.

Role: STUDY_CHAIR

Neonatology, University of Tübingen

Mirja Quante, Dr.

Role: STUDY_CHAIR

Neonatology, University of Tübingen

Michaela Minarski, Dr.

Role: STUDY_CHAIR

Neonatology, University of Tübingen

Johanna Löchner, Prof. Dr.

Role: STUDY_CHAIR

Clinical Psychology, FAU Erlangen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Annette Conzelmann, Prof.Dr.

Role: CONTACT

00497071/29-87513

Annette Conzelmann, Prof. Dr.

Role: CONTACT

00497071/29-87513

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Annette Conzelmann, Prof. Dr.

Role: primary

00497071/29-87513

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

652/2023BO2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Delivery Room Skin-to-skin Study
NCT01959737 COMPLETED NA
Swaddy, a Neonatal Positioning Device.
NCT07270055 NOT_YET_RECRUITING NA